Fetal Pillow for Breech Presentation

Overseen By David A Hill, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: AdventHealth

Disqualifiers: Multiple fetuses, Uterine incision, BMI > 40, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how a special balloon device, called the Fetal Pillow, might assist in turning a baby from a breech position to head-down before birth. The main goal is to determine if lifting the baby's bottom with the Fetal Pillow makes the turning process easier and more successful. The trial includes women pregnant with their first baby, between 37 and 40 weeks, whose baby is breech and who have no medical reasons preventing an attempt to turn the baby. Participants will either have the balloon inflated or not, to compare results. As an unphased trial, this study offers participants the chance to contribute to innovative research that could improve outcomes for breech births.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the Fetal Pillow device is safe for use in external cephalic version procedures?

Research has shown that the Fetal Pillow has been used in studies without causing harm to mothers or babies. This device is placed to help lift the baby's bottom during certain procedures. However, limited information exists about its overall safety in current medical settings. It is important to note that the Fetal Pillow should not be used if a genital infection is present. While the device is generally considered safe, further research could help confirm its safety for all involved. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about elevating the fetal buttocks prior to an External Cephalic Version (ECV) using a Fetal Pillow because it offers a new approach to turning breech babies. Unlike traditional methods like manual manipulation or medication to relax the uterus, this technique involves inflating a balloon device to gently lift the baby's bottom. This could potentially make the turning process easier and safer for both mother and baby, reducing the need for a C-section. By providing a mechanical lift, it may improve the success rate of ECVs without additional medication or invasive procedures.

What evidence suggests that the Fetal Pillow device is effective for elevating fetal buttocks during external cephalic version procedures?

Research has shown that the Fetal Pillow can be helpful during some C-section deliveries. One study found that it improved the baby's blood acidity levels, indicating better newborn health. It is also considered a safe and useful tool for assisting in the delivery of the baby's head during these surgeries. In this trial, participants in the intervention arm will experience the inflation of the balloon device, while those in the control arm will not. However, it remains unclear if it reduces major complications for mothers or babies. Some doctors believe there is enough evidence to support its benefits, but opinions vary. ^{3 6 7 8 9}

Who Is on the Research Team?

Ariana Mora

Principal Investigator

AdventHealth

David A Hill, MD

Principal Investigator

AdventHealth

Are You a Good Fit for This Trial?

Inclusion Criteria

Patient speaks English or Spanish as primary language.

Patient able to understand verbal and written consent

Women delivering at AdventHealth Orlando campus.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Treatment

Participants undergo the external cephalic version (ECV) procedure with either inflation or sham inflation of the Fetal Pillow device

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the ECV procedure, including fetal monitoring and assessment for complications

up to 72 hours

In-hospital monitoring

Post-procedure monitoring

Monitoring for delivery outcomes and costs for the mother and neonate

up to 42 days

What Are the Treatments Tested in This Trial?

Interventions

• Fetal Pillow insertion

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

Inflation of the balloon device

Group II: Control Placebo Group 1 Intervention

Non-inflation of the balloon device

Who Is Running the Clinical Trial?

AdventHealth

Lead Sponsor

Trials

118

Recruited

31,800+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12070017/

The Effect of Using a Fetal Pillow in Second-Stage ... The use of the Fetal Pillow in second-stage cesarean sections did not result in statistically significant differences in most fetal or maternal outcomes.

2. ajog.org ajog.org/article/S0002-9378(22)00858-4/fulltext

Management of impacted fetal head at cesarean delivery A recent meta-analysis demonstrated better umbilical arterial pH in infants with the use of the Fetal Pillow than that of vaginal push-up.

3. obgyn.onlinelibrary.wiley.com obgyn.onlinelibrary.wiley.com/doi/10.1111/aogs.14038

Effectiveness of the fetal pillow to prevent adverse maternal ... The use of the fetal pillow at full dilatation cesarean section appears to be ineffective at reducing significant maternal or fetal complications.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0020729216303125

Comparison of maternal and neonatal outcomes from full ... Conclusion. The Fetal Pillow appears to be a safe and effective aid for the delivery of the fetal head during cesarean deliveries at full dilatation.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11660025/

Obstetrician views on Fetal Pillow® device use and ... Thirty‐six percent of respondents felt 'There is adequate research demonstrating that the Fetal Pillow® is effective at reducing maternal morbidity at full ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/reviews/DEN150053.pdf

De Novo Summary (DEN150053) Page 1 of 14 FDA identifies ... There were no fetal or maternal injuries attributed to Fetal. Pillow use in either the randomized controlled trial or retrospective cohort study. In the.

7. coopersurgical.com coopersurgical.com/wp-content/uploads/2024/01/Fetal-Pillow-Brochure.pdf

Fetal-Pillow-Brochure.pdf The Fetal Pillow is contraindicated in the presence of an active genital infection. The safety and effectiveness of Fetal Pillow has not been established in ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7098440/

Cephalic Elevation Device for Second-Stage Cesarean ... Using a cephalic elevation device during second-stage cesarean deliveries decreases time to delivery after hysterotomy by 23 seconds.

9. sciencedirect.com sciencedirect.com/science/article/pii/S0002937822008584

Management of impacted fetal head at cesarean delivery However, there is an absence of data demonstrating safety, very little evidence for their use in modern obstetrical practice, and a risk of inappropriate ...